RCT Implant Based Breast Reconstruction

Mastectomy Clinical Trial

Official title:

A Randomized Controlled Trial in Patients Undergoing Immediate Implant-Based Breast Reconstruction Utilizing an Enhanced Recovery Pathway Comparing Outcomes and Patient Satisfaction Based on Time of Discharge

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04558138
• Other study ID #: 20-1055.cc
• Secondary ID: P30CA046934
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2020
• Est. completion date: January 5, 2026

Study information

• Verified date: February 2024
• Source: University of Colorado, Denver
• Contact: Christodoulos Kaoutzanis
• Phone: 720-516-9402
• Email: Christodoulos.Kaoutzanis[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to evaluate patients undergoing mastectomy with immediate implant-based breast reconstruction and compare the outcomes of patients who are discharged the day of surgery versus patients who are discharged on post-operative day one. The primary aim of the study will be to compare the postoperative outcomes and complications between the two study groups within 30 days of discharge. The secondary aims of the study will be to compare patient satisfaction, quality of life and discharge perceptions.

Description:

Traditionally patients undergoing mastectomy with immediate implant-based breast reconstruction were admitted to the hospital overnight. However, recent retrospective studies utilizing ERAS protocols have reported same day discharge as a possibility for this patient population. ERAS protocols for breast cancer surgery and reconstruction are becoming more popular. This along with the increasing utilization of prepectoral breast reconstruction that is associated with less postoperative pain and opioid use, are promising avenues to decrease the need for overnight hospital stay. If it can be shown that discharge on the same day of surgery does not pose any major risks compared to discharge on post-operative day one, there is the potential to decrease length of hospital stay, improve hospital capacity and dramatically decrease costs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 5, 2026
• Est. primary completion date: January 5, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients who will undergo immediate, (unilateral or bilateral)implant-based breast reconstruction following mastectomy for breast cancer or prophylaxis at the University of Colorado Anschutz Medical Campus and Highlands Ranch Campus.

2. Patients undergoing sub-pectoral and pre-pectoral breast implant reconstructive techniques will be both included.

3. All adult (>18 years old), female patients who will undergo mastectomy for breast cancer or prophylaxis and immediate implant-based reconstruction who are able to complete surveys independently will be eligible for the study.

4. English and Spanish speaking

5. Patients will be included regardless of their current chemoradiation plan

Exclusion Criteria:

1. Age > 80 years

2. ASA 4

3. suboxone use

4. documented substance use disorder as defined by the DSM-5 (I.e. alcohol use disorder, opioid use disodrer, cocaine use disorder, etc). Marijuana use will not be considered a substance use disorder

5. OSA requiring CPAP

6. recent pneumonia (within 6 weeks)

7. BMI > 45 kg/m2 with any co-morbid condition that is not well controlled

8. poorly controlled diabetes (HgbA1c > 9)

9. Not English or Spanish speaking

Related Conditions & MeSH terms

• Mastectomy

Intervention

Other:
• Discharge timing
Patients will be discharged home on the day of surgery as opposed to POD #1

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of post-operative complications surgical site infection	Assessed by patient report	Up to 30 Days
Primary	Number of Participants with Post-operative hematoma	Assessed by patient report	Up to 30 Days
Primary	Number of Participants with Post-operative blood clots	Assessed by patient report	Up to 30 Days
Primary	Number of Participants with Post-operative emergency department visits	Assessed by patient report	Up to 30 Days
Primary	Number of Participants with Post-operative hospital readmissions	Assessed by patient report	Up to 30 Days
Primary	Number of Participants with Post-operative re-operation	Assessed by patient report	Up to 30 Days
Secondary	Pain Score	Pain control, as measured by a visual analog Numeric Pain Scale (NPS) number ranging from 0 (no pain at all) to 10 (worst pain ever) between the two groups.	Up to 30 Days
Secondary	Opioid Consumption	The following information will be collected from a combination of patient reported information and electronic medical review: amount of supplemental postoperative opioid analgesia (both intravenous and oral) used by the study participant from postoperative days 0 to 7.	Post-Operative day 7
Secondary	Opioid adverse effects	The following effects/symptoms will be recorded as YES or NO if required admission to the hospital for management including use of IV medications: nausea, vomiting, constipation and urinary retention.	Up to 30 Days
Secondary	Quality of life perceptions: QoR-15	QoR-15: This scale will be utilized to evaluate patient satisfaction. It captures patient reported postoperative assessment of various dimensions of health including patient support, comfort, emotions, physical independence, and pain. Patients rate each of the 15 statements from 1 (never) to 10 (always).	Up to 30 Days
Secondary	Discharge perceptions	Group A: Discharged the same day of surgery will be asked the following questions on postoperative 7: Did you feel that you were discharge home at the appropriate time?; How uncomfortable were you the night of surgery, as measured by a visual analog NPS number ranging from 0 (not uncomfortable) to 10 (extremely uncomfortable)?; What was the main benefit of going home right after surgery?; What was your biggest complaint about being at home right after surgery?; Group B: Patients admitted after surgery will be asked the following questions on postoperative 7: Did you feel that you were discharge home at the appropriate time?; How uncomfortable were you the night of surgery, as measured by a visual analog NPS number ranging from 0 (not uncomfortable) to 10 (extremely uncomfortable)?; What was the main benefit of being admitted to the hospital after surgery?; What was your biggest complaint about being at the hospital after surgery?	Post-Operative day 7
Secondary	Quality of life perceptions: PROMIS-29	PROMIS-29: A generic health-related quality of life survey, assesses each of the 7 PROMIS domains with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity part of the PROMIS-29 (with 0 being "no pain" and 10 being "worst imaginable pain")	Up to 30 Days